As reported on McKnights.com, the Patient Safety and Abuse Prevention Act of 2009 (PSAP) was reintroduced to the Senate this week.  The proposed law would expand upon a seven state pilot program that provides funding for nursing homes to conduct Federal Criminal Background checks on all nursing home employees. 

Like many bills introduced in this first Congressional session of the Obama administration, this bill has been around the block a time or two.  In its previous incarnation, the PSAP included a funding provision to conduct federal criminal background checks on potential residents as well as employees, but it appears that provision was dropped to make this new bill more palatable.  This is probably a good “single-subject” modification, as background checks for employees and residents are truly different topics.  And, screening employees with a Federal Criminal background check is too important for the bill to be defeated based on a parallel, but unrelated, analysis. 

To illustrate the point, consider the following from an article in Modern Health Care:

 “Forty-one states require criminal background checks on most aides prior to employment, but only half of those    require criminal background checks at the federal level. In 2004, state agencies reported that they received more than 500,000 reports of elder and vulnerable adult abuse.”

This new version of the PSAP is really a funding bill, more than a mandate.  Essentially, it would open up money, in the form of grants, tying with said money an admonition to conduct checks on all current and future employees, to nursing homes meeting a certain set of criteria (essentially those receiving Medicare money). 

Personally, I am an advocate for this type of bill.  Sure, there is already a huge amount of processin the Long Term Care hiring process.  From CNA databases, state level criminal background checks and some Federal checks, hiring is a costly, and time consuming process.  But, two arguments win out on the other side: 1) Such checks really will keep elders in LTC safe, or at least safer, from criminals moving from one state to another to work in LTC; 2) from a legal liability standpoint, such checks create a prima facie argument that a facility was not negligent in hiring. 

Negligent hiring lawsuits have made hay in the past few years, and not only in health care.  One benefit from so much mandated process in when hiring someone for LTC, is that should the worst happen – – should an employee harm a resident, the facility can insulate itself from the inevitable lawsuit by pointing out that a) the state and federal government require a lot of work from employers before they can hire an employee and b) by doing all of that work, the facility has done everything reasonable within its power to prevent just the sort of harm that has happened.  The failure of this duty is what is at bottom of negligent hiring suits.

So, I welcome the reintroduction of the Patient Safety and Abuse Prevention Act.  Hopefully, this bill will move swiftly through Congress and the president’s desk.   The money from this bill will increase resident safety, and afford LTC providers another shield against the sword of negligence suits.

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Off-label use and Medicare

January 27, 2009

The New York Times released another salvo in the debate over off-label prescription drug use and Medicare payments today.  Its article (available here) discusses a rule change that took effect this past November, opening the so-called “compendium pipeline” for Medicare covered drugs that are used off-label to treat cancer.  The article scants on the issue of costs and focuses primarily on the hoary, ‘actual effectiveness versus patient hope’ debate of off-label use drugs.  I would like to look at the cost effect, but before I head down that rabbit-hole, a brief background may be in order.

Off-Label Use Background

Prescription drugs are approved for specific uses, dosages and combinations by the Food and Drug Administration.  The approval process can have multiple steps, independent verifications of trials, and take anywhere from a long time to a very long time depending on the nature of the drug-use seeking approval and the number of researchers providing data. Physicians and other prescribers are free to issue prescriptions for uses outside of those the FDA specifically approves, and do, mostly to very good effect for the patients involved.  Indeed, the cost and time involved prevent many legitimate uses from gaining FDA approval, so the off-label use mechanism acts as a kind of release valve for the strictures of the FDA approval process.

Medicare and private insurance companies are not always willing to pay for these off-label uses, especially if they are experimental.  Since the mid 1980s, however, CMS has authorized payment for off-label treatments so long as they exist in the compendium pipeline – – off-label uses described in collected reference guides which are put together by independent, private non-profits that compile drug research in the medical literature.  So, if an off-label use is described in one of these compendiums (all things being equal – – and there are complicating factors), Medicare will pay for it.  

Cost Analysis

What the New York Times was reporting on was a change in CMS policy that effectively increased the number of compendiums Medicare would look to for approved (i.e. paid for) off-label uses.  Because of the not-for-profit nature of the groups writing these reference guides, the number had dwindled down to only one in 2007.  The new rule increases that to (probably) five, once CMS approves the compendiums seeking inclusion.

What does this mean in terms of the cost of Medicare?  It is going to climb, and maybe drastically.  Many drugs are approved for only one or two uses.  The demand for them, therefore, is lower than drugs approved for multiple uses (or with multiple therapies).  Opening up the compendium pipeline will see more prescribing off-label for uses that are not as well-proven to work as approved uses.  

Of course, this effect will probably be ameliorated by private insurance companies following suit and agreeing to pay for the same uses that Medicare pays for (thus increasing off-label use and driving down cost), but the issue is not without controversy.  

In terms of the law, I see a potential dispute arising from CMS’s action here.  Medicare is essentially obliged to pay for an off-label use if a compendium lists it  unless one of the other guides specifically advises against it.  Medicare recipients are allowed to challenge CMS actions (including decisions to pay or not pay) through the administrative adjudication.  If an off-label use is disputed by two approved compendiums, a Medicare recipient seeking to have that use paid for has standing to bring such an adjudication.

Tennessee state legislators introduced a bill last month seeking to limit the payout awards for negligent care lawsuits against nursing homes.  If signed into law, this bill would put an effective cap on the pain and suffering piece of the court’s judgment, either at a whole dollar amount (the Tennessee bill suggests $300,000) or a percentage of the so-called actual damages (e.g. medical bills, lost income, etc.).  The sides of the debate on these type of bills line up approximately this way:

Against Caps:

1) To limit the judgment amount in negligent care cases chills the deterrent effect of such lawsuits.  Or, simply put, nursing home owners will not try harder to deliver non-negligent care unless they are convinced to do so with serious lawsuit damages.

2) Lawsuits involving seniors at nursing homes almost inevitably have lower actual damage awards than other negligent care (i.e. medical malpractice) suits because the victims are no-longer working, their loved ones have a greater expectation of their dying(and thus, presumably suffer less at their death), and they are less likely to have a recovering spouse (the presence of a surviving spouse generally increases wrongful death/pain and suffering lawsuits).  Thus, to cap the pain and suffering awards makes such suits less effective at a) compensating the plaintiff/plaintiff’s family and b) deterring the same bad acts in the future (see point 1 above).

For Caps:

1) Analogy to Medical (i.e. hospital and physician) Malpractice: Many states (though notably not Tennessee) limit medical malpractice lawsuits in a number of interesting and creative ways.  The most common of which is to place some kind of cap on the pain and suffering awards of such suits, but another good option is to have an appointed board of specialists review every medical malpractice complaint and evaluate it for merit before the suit goes on to the court.  The rationale is that medical services are in short supply and such measures prevent physicians from leaving one state for another because of “frivolous lawsuits.”  Long Term Care is as well a necessary and limited resource.  Placing these type of caps on judgment amounts will ensure the perpetuity of LTC facilities, but at the same time strike the necessary balance of compensating plaintiffs/improving the delivery of care.  

2) Long Term Care is so heavily regulated, that it is unjust to allow so-called free-judgment lawsuits against LTC facilities.  The state has taken it upon itself to regulate nursing homes, and fine them, sometimes heavily, for violations of those regulations.  Plaintiffs should not be allowed to seek extravagant compensation on top of this statutory punishment when negligent care occurs.  A judgment cap is exactly the right maneuver to seek a just balance between compensating plaintiffs and preserving a highly regulated industry.  

Conclusion

Tough one.  There are more (and more subtle arguments) out there on this debate.  But, it is interesting to think through.  On some bottom level it comes down to how nursing homes are going to be considered in the future.  Are LTC facilities businesses like retailers and dealerships, delivering care for cash, preserving the bottom line for shareholders?  Are they a public trust, something to be preserved as a community resource above most every other consideration?  Should they be considered something all-together different?  Some combining balance?  

It is a good discussion.

Nursing home administrators face an unexpected ethical (and legal) dilemma when admitting new residents to skilled nursing care. The Nursing Home Care Act undercuts a traditional notion of informed consent in such a way that many residents may be admitted to a nursing home without ever consenting to treatment, or having a meaningful surrogate consent to their treatment. This is clearly an issue of nursing/medical ethics, as well as a font of potential legal liability for providing unauthorized care.

American health care law is predicated on the notion of patient autonomous-direction. Within this notion exist a number of inter-linked rights: the right to self-determination, the right to give consent before treatment, the right to information forming the basis of consent and many others. Curiously, in senior care, as in perhaps no other major area of American health care law, the status of patient autonomous direction, especially with respect to consent before treatment, is less sacrosanct, the exceptions more numerous. This is especially true in the legal quagmire of involuntarily placing adults in nursing homes.

I am most familiar with the Illinois Nursing Home Care Act and it will thus form the background of this discussion, but the Illinois Act is not dissimilar to Nursing Home Care Acts in many other states, at least inasmuch as the acts address the issue of involuntary admission. Clearly involuntary admission of a resident to a nursing home presents moral and ethical issues most families are not experienced in dealing with, not to mention attendant feelings of guilt for the family members and likely betrayal for the patient herself. However, for the health care provider, the nursing home, the struggle is a balance between determining the self-interest rights of the resident and the interests in rendering care.

Admission with Consent/Admission with a Surrogate’s Consent

In Illinois, the default position is that every resident, regardless of diagnosis or infirmity, is presumed to have the capacity to make her/his health care decisions. This includes admission into a nursing home. Providing nursing home care to a person who has capacity to refuse such care, and does refuse it, is paramount to a battery on the patient by the nursing home and would subject the home to potential liability. Determining incapacity is generally a court adjudication, relying in part on advice from a physician, looking at the patient’s ability to make decisions, understand the consequences of one’s own actions and comprehension of one’s diagnosis. If a court determines a person does not possess the capacity to give consent to health care, then a guardian will be appointed to that person to make decisions regarding the person’s health care.

Interestingly, a guardian cannot make the determination to admit her charge into a nursing home unless given express authority by the court to make such a decision. Thus, it is possible (and happens often enough to be noteworthy) where a guardian (usually a family member) who made the decision on behalf of her charge to admit the patient into a hospital must seek specific direction from the issuing court to admit her charge into a nursing home upon discharge from the hospital. Support for this position is fairly widespread and is a outgrowth of the importance of autonomous determination in American health care. In brief: nursing home care is seen as different enough from other provider types, that the type of front-line health care that a guardian usually makes decisions on (administration of prescriptions, whether to have certain hospital-based treatments, etc.), that the decision to admit a patient into a nursing home represents in effect a different, more substantial level of capacity for the court to determine.

Assuming a guardian is granted the authority to admit her charge into a nursing home, this consent will suffice to protect the nursing home from liability, regardless of the manifest wishes of the patient. Yet, the Illinois Act allows for different surrogates other than those specifically appointed by the court to contract with nursing homes for the admission of their charges or wards. A resident may plan for her own incapacity, and avoid the lengthy process of court-ordered and controlled guardianship, by designating a surrogate using a Durable Power of Attorney for Health Care. The Illinois Nursing Home Act creates a statutory form that families can use, although the statutory form has generated many criticisms from commentators because its confusing language may belie the “consent” such forms are supposed to evidence. Such surrogates can consent to nursing home admission so long as the Power of Attorney does not contain language that bars the surrogate making such a decision, either in the presence of manifest intent by the patient/principal, or under any circumstance. Barring this unusual direction in the document itself, a Durable Power of Attorney for Health Care is the most used and safest way residents are involuntarily admitted to nursing homes.

Chipping Away at Informed Consent in the Nursing Home Setting

However, in the absence of a legal surrogate relationship (either a court-directed guardianship or non-exempt Durable Power of Attorney for Health Care), the Illinois Nursing Home Care Act still allows some elements of informed consent to be chipped away. For example, a member of the patient’s family can contract for her admission to a nursing home on the patient’s behalf in the absence of her (the patient’s) positive, manifest consent. This contract is legally binding on the patient/resident so long as she does not object to it once admitted to the nursing home. Thus, a patient can be admitted to a nursing home, a major life change, even when no formal surrogate relationship exists.

The potential harm to patient’s rights caused by the loophole should not be underestimated. Going into a long term care facility represents a major life change for the resident. Generally, they are moving into a new and unknown environment while being taken care of by a physician and nursing staff. Once they are admitted to the nursing home, many residents may be hesitant to voice any objections to their admittance because of cultural imperatives that they do not disagree with medical staff, financial difficulties of living at home and the reluctance to go against the decisions of younger family members who have already arrived at the conclusion that the nursing home is the best place for their continued care.

By requiring only an objection to admission, rather than traditional informed consent, nursing home administrators may be severely impinging on the rights of the residents they serve.

Legal Analysis/Future Action

The legislative history of the Illinois Nursing Home Care Act is disquietingly silent on the issue of creating a statutory distinction between requiring consent for admission and mere objection. Some commentators have described this distinction as being, perhaps, only a scrivner’s error originally, but have harshly criticized the fact that the language creating the distinction has not been changed. They see this as a departure from the foundational premise of patient autonomous-direction.

Whether intentional or not, the artificial distinction serves to create wiggle-room in the informed consent arena that did not previously exist. Given the nature of nursing home care (i.e. a major life-shift for most residents who may be too vulnerable to actually object to admission once they are in the facility), such a distinction creates a potential liability problem for nursing homes and, more importantly, a major ethical concern for providers.

In Illinois this issue has not been addressed by the courts, though there is mounting pressure in the long term care community for some kind of legislative action. The convenience of family members being able to contract with long term care facilities in the absence of express, manifested informed consent by the patient goes against the long tradition of patient autonomous-direction in American health care. Involuntary admission to a nursing home is serious enough that it should be a deliberate decision, a willful cross of the intent of the patient with all of the moral and legal protections and processes that have been created to protect the rights of patients as much as is proper. It should not be a back door policy, a mere absence of objection.